BABI*PLUS BUBBLE PAP VALVE

K090317 · A Plus Medical · BYE · May 20, 2009 · Anesthesiology

Device Facts

• Record ID: K090317
• Device Name: BABI*PLUS BUBBLE PAP VALVE
• Applicant: A Plus Medical
• Product Code: BYE · Anesthesiology
• Decision Date: May 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.

Device Story

Babi*Plus Bubble PAP Valve is a single-patient-use water seal positive end expiratory pressure (PEEP) device. It functions by increasing end lung pressure above atmospheric levels under constant flow conditions. Used in hospital critical care settings for neonates and infants. Device connects to respiratory circuits to provide bubble CPAP therapy. Healthcare providers monitor the device to ensure appropriate pressure delivery. Benefits include non-invasive respiratory support for infants requiring elevated lung pressure. Operation is limited to hospital environments; contraindicated for patient transport or non-hospital use.

Clinical Evidence

Bench testing only. Testing confirmed accuracy of the device at gas flows from 1 to 12 liters per minute and compliance with ISO 5356-1:2004 standards for conical connectors.

Technological Characteristics

Single-patient-use water seal PEEP valve. Conical connectors meet ISO 5356-1:2004. Operates via water seal mechanism for pressure regulation. Designed for constant flow conditions (1-12 LPM).

Indications for Use

Indicated for infant patients weighing < 10 Kg requiring elevated lung pressure therapy in hospital environments. Contraindicated in individuals not requiring elevated lung pressure therapy.

Regulatory Classification

Identification

A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

Predicate Devices

• Water Seal PEEP Valve (Preamendment device)
• Disposable PEEP Valve (K082092)
• Disposable PEEP Valve (K902062)

Submission Summary (Full Text)

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A Plus Medical
Solutions for Respiratory Care

# 510(k) Summary

### Owner:

A Plus Medical 5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 + 760-930-4025 Tel: + 760-930-0040 Fax:

Owner/Operator Number: 10023166

## Official Contact:

Thomas C. Loescher Tel: + 760-930-4025 Fax: + 760-930-0040

Trade Names: Babi*Plus Bubble PAP Valve

Common/Usual Name: PEEP Valve, CPAP Valve, PAP Valve, Bubble CPAP

# Classification Name:

Device Name: Attachment, Breathing, Positive End expiratory Pressure Product Code: BYE Regulation: 868.5965 Device Class: 2

Device: Babi*Plus Bubble CPAP Valve

### Predicate Devices:

| Number: | Preamendment device |
|----------------|-------------------------------------------------------------------------|
| Product Name: | Water Seal PEEP Valve |
| Manufacturer: | unknown - believed to be McGaw Laboratories |
| Product Codes: | Unknown |
| Number: | K082092 |
| Product Name: | Disposable PEEP Valve |
| Manufacturer: | GaleMed Corporation |
| Product Codes: | 2421-2425, inclusive and 2461-2481, inclusive |
| Number: | K902062 |
| Product Name: | Disposable PEEP Valve |
| Manufacturer: | Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC) |
| Product Codes: | LIFESAVER® PEEP Valve Models 5383 and 5385 |

5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 図 [phone] Fax: [phone] ~ 13 ~

MAY 20 2009

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Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical Solutions for Respiratory Care. The logo features the letter "a" in a circle on the left, followed by the words "A Plus Medical" in a larger font. Below "A Plus Medical" is the text "Solutions for Respiratory Care" in a smaller font. The logo is black and white.

### Device Description:

Single patient use water seal positive end expiratory pressure device.

#### Indications for Use:

The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.

#### Contraindications:

Contraindicated in individuals not requiring elevated lung pressure therapy.

#### Patient Population:

Patient populations from neonate to infant.

#### Environment of Use:

Hospital

# Comparative of Technological Characteristics:

The A Plus Medical Babi*Plus Bubble PAP Valve is substantially equivalent in indications for use, environment of use, patient population, material and function to the identified predicate and to devices that were in the market before 1976 and/or the post 1976 identified predicates. The A Plus Medical Babit PAP Valve and identified predicate device meet the requirements set forth ISO 5356- 1:2004 entitled "Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets". Bench testing confirmed the accuracy of the A Plus Medical BabitPlus Bubble PAP Valve and predicate device at gas flows from 1 to 12 liters per minute.

#### Conclusion:

The A Plus Medical Babi*Plus Bubble PAP Valve is substantially equivalent to the predicate devices that were in the market before 1976 identified predicates. The A Plus Medical Babi*Plus Bubble PAP Valve and all identified predicates have substantially equivalent performance. Both devices are made from substantially equivalent material, intended use and patient populations. The A Plus Medical Babi*Plus Bubble PAP Valve is limited to use in acute hospital critical facilities and is contraindicated in individuals not requiring elevated end expiratory pressure, gas flows over 12 LPM, patient transport or non hospital use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

Public Health Service

MAY 20 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas C. Loescher, R.R.T. President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008

Re: K090317

Trade/Device Name: Babi*Plus Bubble PAP Valve Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: April 24, 2009 Received: April 28, 2009

Dear Mr. Loescher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2- Mr. Loescher

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

(a))

| 510(k) Number: | K090317 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Babi*Plus Bubble PAP Valve |
| Indications for Use: | The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> or Over-the-counter use __<br>(21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

(Division Sign-Uff) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(K) Number: _______________________________________________________________________________________________________________________________________________________________